In the medical field, various containers have been used to hold medical solutions such as blood, hemoglobin solutions or other blood substitutes, chemotherapeutic solutions, and other intravenous drip solutions. Frequently, these containers are bags which are either molded or fabricated from flexible plastic so they include one or more expandable chambers for holding medical solution. Additionally, one or more spouts generally extend outward from the chambers for filling and/or draining the container. These spouts are closed to seal the chambers until they are ready to be emptied.
Labels are usually applied to the container for carrying information regarding the medical solution held by the container. For instance, the label may describe the chemical composition of the solution held in the container, it may provide information regarding the origin or use of the medical solution, and/or it may provide regulatory information concerning the medical solution. Various agencies, including regulatory agencies, and jurisdictions generally require certain information to be present on the label in a specific form. For instance, regulatory agencies typically require the information to be provided in one or more specific languages.
Conventional small-volume solution containers have labeling space for only a limited amount of information. As a result of this limitation, a single label fixed to the container and providing all the information required by multiple regulatory agencies cannot be made. Therefore, medical solution manufacturers and distributors must anticipate where solutions will be needed and label the containers appropriately. However, this creates additional inventory problems. Alternatively, the manufacturers and distributors can wait until an order is placed and then label the containers so they include the information in the appropriate form required by the agency or agencies regulating the destination jurisdiction. However, both of these alternatives create problems and add expense to the distribution process.
Further, when the medical solution requires refrigeration prior to labeling, condensate forms on the exterior of the container as it warms. This condensate hampers labeling because adhesives may not stick to the wetted container. In addition, inks may run and become illegible if they come in contact with the condensate.
An additional problem includes the use of overpouches in conjunction with the medical container. When packaging the medical solution containers for shipment, the containers are generally placed in an overpouch. An overpouch is used to protect the medical container during shipment and storage. The overpouch usually takes the form of a bag which can be sealed following insertion of the medical solution container. However, protecting medical containers with overpouches is expensive and inefficient.
When using an overpouch, the medical container must be physically placed into an additional element. Thus, the manufacturer must not only manufacture the medical container itself, but must also manufacture or stock the overpouch. This increases cost and assembly time. Additionally, the overpouch itself is not often made of a material which can be easily seen through for visual inspection of the medical container itself, the information on the label of the medical container or the contents of the medical container. It is very important that the contents of the medical solution be visible to those who work with the medical containers such that a quick and detailed inspection of the solution for particulate matter, precipitates, or other visualizable contaminants, along with the information on the labeling of the container, can be performed. Thus, the use of a separate overpouch has several drawbacks.